{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-384403","form_type":"8-K","ticker":"DFTX","cik":"0001813814","company_name":"Definium Therapeutics, Inc.","filed_at":"2026-09-08T12:00:15+00:00","discovered_at":"2026-09-08T12:05:01.444391+00:00","generated_at":"2026-09-08T12:05:19.283058+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Definium gets second FDA Breakthrough Therapy designation for DT120 in MDD","bullets":["FDA granted Breakthrough Therapy designation for DT120 ODT in major depressive disorder; second BTD for program after GAD.","Phase 3 Emerge: single 100 µg dose showed 8.1-point placebo-adjusted MADRS improvement at Week 6 (p<0.0001), durable to Week 12.","MDD affects >21M US adults annually; fewer than one-third of patients reach remission with current treatments.","CEO Rob Barrow says designation underscores DT120's potential to transform treatment for serious mental health disorders."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-384403","json":"https://secwatch.observer/filing/0001193125-26-384403.json","markdown":"https://secwatch.observer/filing/0001193125-26-384403.md","text":"https://secwatch.observer/filing/0001193125-26-384403.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1813814/000119312526384403/0001193125-26-384403-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1813814/000119312526384403/dftx-20260908.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-08T12:05:19.283058+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}